Kornimate/medical-research-clean huggingface dataset:
a time-to-effect based dosing strategy in cryoballoon ablation of patients with paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary vein ablation procedures in patients with paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: * patients with at least 2 documented episodes of paroxysmal atrial fibrillation (af) which are not responders to at least one antiarrythmic drug exclusion criteria: * previous left atrial ablation procedure or surgery * left atrium diameter \> 50mm * presence of intracardiac thrombus * left ventricular ejection fraction \< 40% * heart failure class iii-iv * severe valvulopathies * acute coronary syndrome or cardiac surgery within the previous 3 months of enrollment * transient ischemic attack/stroke within the previous 6 months of enrollment * life expectancy less than 1 year * any contraindication to the procedure according to the current clinical practice

Keywords: cryotherapy
telmisartan in haemodialysis patients with chronic heart failure

Conditions: Heart Failure, Congestive

Summary: background: in haemodialysis patients, chronic heart failure (chf) is responsible for a high mortality rate but, presently, very little data is available regarding this population. aim of the study: aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in haemodialysis patients with chf and impaired left ventricular ejection fraction (lvef) when added to standard therapies with ace inhibitors. methods: a 3-year randomized, double-blind, placebo-controlled, multicentre trial was performed involving 30 italian clinics. haemodialysis patients with chf (nyha class ii and iii; lvef 40%) were randomized to telmisartan or placebo in addition to ace inhibitor therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. mean follow-up period was 35±5 months. primary outcomes were all-cause mortality, cardiovascular mortality and chf hospitalization.


Eligibility criteria:
inclusion criteria: * adult haemodialysis patients with chf; * new york heart association (nyha) class ii and iii; * ejection fraction less or equal to 40% determined within 6 months; and * therapy with ace inhibitors individually optimized and unchanged for 30 days before randomization exclusion criteria: * hypotension during dialysis; * atrial fibrillation; * intolerant to low dose of telmisartan

Keywords: heart failure haemodialysis telmisartan angiotensin converting enzyme inhibitor
post-marketing surveillance study to observe inlyta® treatment dosing pattern, safety and effectiveness in taiwan real world routine practice

Conditions: Renal Cell Carcinoma

Summary: this is a post-marketing surveillance study to observe inlyta® treatment dosing pattern, safety and effectiveness in taiwan real world routine practice. the primary objective of this registry is to monitor the dose adjustment of inlyta® in real world routine practice. the secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.

this is a multi-center chart review registry on mrcc patients treated with axitinib. primary objective is the dose adjustment. secondary objectives are safety profile, objective response rate and progression free survival. efficacy assessment will be based on investigators' judgment. patients treated with 1st dose of axitinib between may 7, 2013 and june 30, 2015 will be enrolled. the follow-up time is 12 months. prior therapies should include sunitinib or interferon alpha.

Eligibility criteria:
inclusion criteria: * patients diagnosed as advanced rcc by histology or cytology * patients using axitinib as therapy after failure of sunitinib or cytokine * patients received axitinib treatment and follow up in the health care center participating present registry * patients agree to participate and signed inform consent or irb waiving of signed informed consent document is available exclusion criteria: * patients with first dose of axitinib earlier than 7th may 2013 * patients with first dose of axitinib later than 30th june 2015. * patients participating in clinical research involving axitinib * patients with hypersensitivity to axitinib or to any other component of axitinib * patients under 18-year of age * pregnant women.

Keywords: advanced renal cell carcinoma, disease progression, sunitinib, interferon alpha
intravenous immunoglobulin after relapse in vasculitis

Conditions: ANCA + Vasculitides Relapsing Either Under Corticosteroid; and Immunosuppressant Therapies or After One Year; Post Treatment.

Summary: the aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.

the aim of this study will assess the effects of intravenous immunoglobulin in anca+ vasculitides (microscopic polyangiitis, wegener's granulomatosis and churg-strauss syndrome) who relapse under corticosteroid and immunosuppressant therapies or after one year post treatment.

Eligibility criteria:
inclusion criteria: * wegener's granulomatosis, microscopic polyangiitis and churg-strauss syndrome (satisfying acr or chapel hill classification) relapsing either under corticosteroid and immunosuppressant therapies or after one year post treatment * age \> 18 years old * written informed consent exclusion criteria: * systemic vasculitides not previously treated with corticosteroid and immunosuppressant(s) * systemic vasculitides treated with corticosteroids and immunosuppressant therapies, but with treatment cessation more than 12 months ago * polyarteritis nodosa * absence of poor prognosis criteria (according to ffs) * nephritis ± renal impairment * cancer or malignancy * psychiatric disease, lack of compliance * age under 18 years old * lack of written informed consent * other vasculitides (post viral infection and skin localisation)

Keywords: anca associated vasculitides relapse intravenous immunoglobulins corticosteroid immunosuppressant
safety and efficacy of the effect of isosorbide mononitrate in reducing pain during levonorgestrel-releasing intrauterine device insertion

Conditions: Contraception

Summary: the aim of the study is to evaluate the safety and efficacy of isosorbide mononitrate vaginal administration in reducing pain during lng-iud insertion in adolescents and young women


Eligibility criteria:
inclusion criteria: * adolescents and young women requesting lng-iud insertion exclusion criteria: * heavy vaginal bleeding,pregnancy, contraindications to iud insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
turkish validation and reliability of lurn si-29 questionnaire in patients with lower urinary tract symptoms

Conditions: Lower Urinary Tract Symptoms; Urinary Incontinence

Summary: lower urinary tract symptoms is quite frequent in men and women. to better understand the the symptoms that characterize lower urinary tract, the national institute of diabetes and digestive and kidney diseases (niddk) has established the symptoms of lower urinary tract dysfunction research network (lurn). in this study we aim to validate the lurn-29 score to turkish language


Eligibility criteria:
inclusion criteria: * patients with lower urinary tract symptoms, over 18 years old,patient with the cognitive ability to read exclusion criteria: * patients above 18 years old

Keywords: lower urinary tract symptoms patient reported outcomes questionnaire
analysis of the effectiveness of neoadjuvant chemotherapy in the treatment of colon cancer locally advanced (elecla)

Conditions: Locally Advanced Colon Cancer

Summary: effectiveness analysis of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer. elecla trial

participants in this study selected patients according to homogeneous inclusion criteria and will be treated either with a uniform protocol of neoadjuvant chemotherapy, surgery and complementary chemotherapy (intervention group), or with the standard scheme of postoperative surgery and chemotherapy (control group ). all patients will be studied basally through clinical examinations and radiological and endoscopic tests usually used to reach the diagnosis of locally advanced colon cancer . in the group of patients receiving neoadjuvant treatment, the ct scan will be repeated after the completion of preoperative chemotherapy to restage the disease and quantify the degree of tumor response. finally, the project tries to determine whether the neoadjuvant treatment scheme increases disease-free survival (sle) at 2 and 5 years and overall survival (os) at 5 years. likewise, the toxicity derived from chemotherapy treatment and perioperative morbidity and mortality will be analyzed to evaluate the feasibility and safety of the therapeutic procedure. the rate of completion of chemotherapy in both groups will also be compared.

Eligibility criteria:
inclusion criteria: * clinics 1. histological confirmation of colon adenocarcinoma. 2. patients of both sexes with age over 18 years. 3. good general condition of the patient (karnofsky\> 60% or ecog (eastern cooperative oncology group) \<2). 4. analytical at the time of inclusion with figures of hemoglobin\> 10 g / dl; leukocytes\> 3.0 109 / l, platelets\> 100,000, glomerular filtration\> 50 ml / min and total bilirubin \<25 micromol / l. 5. absence of contraindication for chemotherapy. 6. acceptance and signature of the informed consent. * of image 1. radiological signs, evaluated by ct, of t4 or t3 tumor infiltration\> 5 mm of transmural invasion. 2. with or without lymph node involvement by ct. 3. no metastatic involvement in other organs (m0). 4. radiologically resectable disease. references to the treatment 1. that they will undergo elective surgery with curative intent (r0). exclusion criteria: * 1. important comorbidity, uncontrolled angina or a history of acute myocardial infarction in the last 6 months. 2. personal history of another malignancy in the last 5 years, with the exception of melanoma. 3. uncontrolled infection 4. pregnancy or lactation. 5. peripheral neuropathy\> grade 1. 6. rectum cancer (\<15 cm of the anal margin or below peritoneal reflection). 7. presence of distant metastasis or peritoneal carcinomatosis. 8. intestinal obstruction. 9. existence of microsatellite instability 10. refusal to participate or to give written consent 11. impossibility, at the investigator's discretion, to understand the purpose of the study or to comply with its procedures.
trial comparing a strategy based on molecular analysis to the empiric strategy in patients with cup

Conditions: Neoplasms, Unknown Primary

Summary: this is a european randomised, phase iii, multi-centric study comparing a diagnostic and therapeutic strategy based on molecular analysis followed by suspected primary cancer tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown primary. the purpose of this trial is to determine whether or not a strategy based on molecular analysis is effective in improving the progression free survival rates of patients with carcinoma of unknown primary (cup).


Eligibility criteria:
inclusion criteria: 1. patients presenting with carcinoma of unknown primary, confirmed by histopathological analysis (including an immunohistochemical analysis) and corresponding to one of the following histologic types : moderately or well-differentiated adenocarcinoma, poorly-differentiated adenocarcinoma, undifferentiated carcinoma, squamous-cell carcinoma 2. diagnostic work-up in keeping with standard options recommandations des capi (lesimple et al., 2003), 3. age \> 18 years, 4. performance status 0, 1 or 2 according to ecog 5. good or poor prognosis cup classified according to the gefcapi classification 6. cup with at least one measurable lesion 7. tumour sample available for molecular analysis 8. cup not belonging to a subgroup requiring a specific treatment, 9. satisfactory haematological, renal and hepatic function 10. cardiac, respiratory and neurological function compatible with the administration of cisplatin chemotherapy, 11. no previous chemotherapy for a cup 12. previous radiotherapy is acceptable, but it should be completed at least 4 weeks before the start of systemic treatment. randomization can be performed during this time frame. 13. all patients with reproductive potential must practice an effective method of birth control throughout the study. female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment 14. information delivered to patient and informed consent form signed by the patient or legal representative. exclusion criteria: 1. patients in whom the diagnosis has not been histologically confirmed (a cytological analysis alone does not permit patient entry onto the trial), 2. patients with known hiv infection 3. patients with symptomatic brain metastases, 4. associated disease likely to prevent the patient from receiving the treatment, 5. previous history of cancer (excepted skin basocellular epithelioma or epithelioma in situ of the uterine cervix) during the 5 years before study entry, 6. patients already included in another clinical trial with an experimental therapy, 7. pregnant woman or woman who are breastfeeding, 8. compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.
a phase ib study of mek162 plus byl719 in adult patients with selected advanced solid tumors

Conditions: Advanced and Selected Solid Tumors; AML; High Risk and Very High Risk MDS

Summary: this is a multi-center, open-label, dose-finding, phase ib study to estimate the maximum tolerated dose(s) (mtd(s)) and/or recommended dose(s) for expansion (rde(s)) for the orally administered combination of byl719 and mek162. this combination will be explored in adult patients with advanced crc, esophageal cancer, pancreatic cancer, nsclc, ovarian cancer, or other advanced solid tumors and in adult patients with aml or high risk and very high risk mds, with documented ras or braf mutations. dose escalation will be guided by a bayesian logistic regression model with overdose control. at mtd or rde, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of byl719 and mek162 in specific patient populations.


Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed, advanced solid tumors, aml or high risk and very high risk mds * measurable disease as determined by recist 1.1 exclusion criteria: * primary cns tumor or cns tumor involvement * diabetes mellitus * unacceptable ocular/retinal conditions * clinically significant cardiac disease or impaired cardiac function

Keywords: advanced solid tumor, aml high risk and very high risk mds dose escalation, ras/braf mutation, pi3k inhibitor, mek inhibitor, byl719, mek162
ventilatory responses to hypercapnic and hypoxic conditions in hyperventilants

Conditions: Hyperventilation Syndrome; Hypercapnia; Hypoxia

Summary: for almost a century, many hypotheses have converged on the idea of altered chemosensitivity in patients suffering from hyperventilation syndrome (hvs). given the evolution of current technical equipment and the ability to maximise true positives in hvs ( using the revised hyperventilation provocation test), it seems reasonable to investigate central and peripheral chemosensitivities in hvs subjects.

in the inter-war period, many medical investigators who studied the hyperventilation syndrome (hvs) had already questioned the chemosensitivity to co2 in hvs patients, without being able to explore it for all intents and purposes. it was subsequently observed that although hvs is not systematically linked to manifest resting hypocapnia, it is nevertheless systematically correlated with significant variability and complexity of ventilation. this is consistent with the observations of an increased plant gain in hvs, to be related to an increased loop gain (due to instability of controller gain feedback). on the other hand, some authors already noted that, when capnia is chronically compromised in hvs, it can be greatly altered by small, transient and barely perceptible increases in ve: a 10% increase in ve could indeed halve petco2, while a sigh would be able to decrease petco2 by up to 15mmhg. more recently, teh assumption was made that peripheral chemosensitivity may be impaired in hvs patients. for all these considerations, it seems reasonable to investigate central and peripheral chemosensitivities in identified hvs subjects on the basis of an objective test, such as the induced hyperventilation test.

Eligibility criteria:
inclusion criteria: * a plethysmography within subject's predicted values * a negative metacholine test (no documented allergy) * a hyperventilation provocation test result that is consistent with the nijmegen questionnaire score, confirming either group classification (hvs+ or hvs-) exclusion criteria: * each of the following known or documented conditions: chronic bronchitis (copd), emphysema, asthma, cardiac disorder, neurological disorder, gastrointestinal disorder, thyroid disorder or psychological/psychiatric disorder * suspicious cardio-pulmonary exercise testing (cpet) with cardiac or respiratory limitation * pregnant women or women in the process of becoming pregnant * persons with a diving practice (amateur or professional), * high-level athletes, * active smokers and * persons using morphine, and/or barbiturates, and/or anxiolytics and/or sleeping pills
single iv dose of glyx-13 in patients with treatment-resistant depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine whether glyx-13 reduces depression score in patients with treatment-resistant depression.


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder consistent with dsm-iv-tr * current episode greater than 8 weeks in duration * hamilton depression score \>/- 21 * less than 25% reduction in depression during current episode assessed by atrq exclusion criteria: * axis diagnosis of other psychiatric disorders * experiencing hallucinations, delusions, other psychotic symptomatology * ect during current episode

Keywords: depression nmda antagonist treatment resistant
low intraocular pressure cataract surgery with zeiss quatera in glaucoma patients

Conditions: Cataract; Glaucoma

Summary: you were selected to participate in this observational study because you suffer from glaucoma and cataracts. for the cataract you will have cataract surgery. this study will not affect your treatment, it will only collect data on what is performed before, during and after the procedure. the aim of this data collection is to demonstrate the safety of a new generation of cataract surgical devices in patients who also suffer from glaucoma. they are glaucoma patients who have an increased sensitivity to eye pressure increases both during and after surgery. the new surgical device makes it possible to safely perform cataract surgery under low pressures. this could, at least theoretically, provide an advantage for patients who also suffer from glaucoma.

cataract surgery is a highly standardized procedure. however a new phacoemulsification system "quatera 700" has been developed by carl zeiss meditec. the system has a unique patented quattro pump that directly controls infusion and aspiration and enables a synchronous change in both. it has four membranes, which directly regulate infusion and aspiration and maintain a pre-set intraocular pressure (iop), resulting in a stable anterior chamber during the surgery. the membranes are activated by pneumatic pressure regulated by sensors that measure infusion and aspiration flows which allows the system to determine and compensate for incisional leakage as well. this innovative pump system allows surgeons to significantly decrease the intra-ocular pressure during cataract surgery. in respect to competitive devices on the market, the quatera system is able to operate with pressure four times lower than average. especially in glaucoma patients (patients suffering from optic nerve head damage due to elevated intraocular pressures), performing surgery with lower intra-ocular pressures would help in avoiding extra nerve fiber layer damage and overall safety of the surgery.

Eligibility criteria:
inclusion criteria: * patients diagnosed with glaucoma that are diagnosed with age-related cataract exclusion criteria: * unwilling to sign informed consent * functionally monophtalmic patient * endothelial dystrophy * active uveitis * known corticosteroid responder * presence of uncontrolled systemic disease

Keywords: intra ocular pressure cataract quatera glaucoma
efficacy and safety of sugammadex in renal diseased patients

Conditions: Kidney Failure, Chronic; Neuromuscular Blockade

Summary: the purpose of this study is to determine whether sugammadex reverses a profound neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as effectively and safely as it does in patients with normal renal function.

sugammadex antagonizes rocuronium induced neuromuscular blockade by encapsulating the molecules of this agent in the plasma and originating a complex which is highly stable, and mainly eliminated by the kidneys. in patients with end stage renal disease, this complex remains in the circulation for days. previous studies have shown that sugammadex adequately reverses the blockade induced by rocuronium in such patients, and no evidence of recurrence was observed after a dosis of 2 mg/kg administered to reverse a moderate level of blockade. to our knowledge, nothing has been published so far on the reversal of profound blockade by sugammadex in patients with renal failure. the aim of our study was to evaluate the efficacy and safety of sugammadex in the reversal of profound neuromuscular block (nmb) induced by rocuronium in patients with end-stage renal failure and compare it to patients with normal renal function.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years old * end-stage renal disease defined by clearance of creatinine \< 30 ml/min * normal renal function defined by clearance if creatinine \> 90 ml/min * candidates to elective surgical procedures (control group) or kidney transplantation (renal group) under general anaesthesia exclusion criteria: * pregnant and breastfeeding women * patients with known or suspected neuromuscular disorders * patients with hepatic disfunction * a history of malignant hyperthermia * allergy to narcotics, rocuronium or other medication used during general anaesthesia * patients receiving medication known to interfere with the action of rocuronium (amino glycoside antibiotics, anticonvulsants, or magnesium)

Keywords: complications, renal; kidney, failure; neuromuscular block, antagonism; neuromuscular block, rocuronium; safety, drug sugammadex